Roche has acquired Promedior, a biotechnology company, and its full portfolio of molecules to possibly treat fibrotic diseases. The portfolio includes PRM-151, a lead therapy candidate for idiopathic pulmonary fibrosis (IPF) advancing in clinical testing.
PRM-151 is a synthetic engineered version of pentraxin-2, a protein that is able to regulate the immune system to naturally turn off and reverse fibrosis. This protein can also help to remove and possibly heal scarred tissue.
“Due to Roche’s strong expertise in IPF, hematological cancer and other fibrotic disorders, we believe Roche is ideally positioned to bring the potential of our platform to patients and provide new treatment options within these areas of urgent unmet medical need,” Jason Lettmann, CEO of Promedior and general partner of Lightstone Ventures, said in a press release.
“We are excited to combine Promedior’s portfolio with our drug development capabilities to further advance PRM-151 in fibrotic diseases, including IPF and myelofibrosis,” said James Sabry, MD, PhD, global head of Roche Pharma Partnering.
The U.S. Food and Drug Administration (FDA) designated PRM-151 a breakthrough therapy in March as a potential IPF treatment.
Its decision was based on results from a Phase 2 clinical study (NCT02550873) that compared the efficacy of treatment with PRM-151 to placebo in 117 IPF patients enrolled at sites in the U.S. and Europe.
PRM-151 was given via intravenous injection (directly into the vein) at a dose of 10 mg/kg on days one, three, and five in the first week of each cycle, followed by one infusion every month over a total of seven months (28 weeks).
Trial findings showed that patients given PRM-151 had slower lung function decline, as measured by forced vital capacity (FVC), by the end of the treatment compared to those in the placebo group. An average FVC decline of 2.5% was reported in people using PRM-151, and a decrease of 4.8% in those on placebo.
PRM-151-treated participants also showed better exercise capacity, as measured by the six-minute walk test.
Additional data from a 76-week open-label extension study, published in the journal Lancet Respiratory Medicine, provided evidence of a sustained benefit in overall functional decline with PRM-151 treatment.
With these data and and the FDA’s support for its proposed trial design, Promedior announced plans to open a Phase 3 clinical study in IPF patients.
“With our proven track record in IPF with Esbriet [an approved IPF therapy] as well as in hematological cancers, we are well-positioned to leverage our clinical and commercial expertise to bring PRM-151 to patients as fast as possible,” Sabry said.